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Alaris 9601 (UDI 10885403960123)Recalls & reported problems

Carefusion 303, Inc. · Alaris Systems Manager v12-12.5.1 · Class 2

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Feb 18, 2025Open, Classified

    Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

    Z-1304-2025 · Root cause: Under Investigation by firm · FDA record ↗

  2. May 21, 2024Open, Classified

    Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.

    Z-2262-2024 · Root cause: Under Investigation by firm · FDA record ↗

Other Infusion safety management software devices

All Infusion safety management software devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.